Ignite Creation Date:
2024-05-06 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01772875
Status:
WITHDRAWN
Last Update Posted:
2020-08-05
First Post:
2013-01-17
Brief Title:
Bladder Lavage as Decontamination Method for Asymptomatic Bacteriuria With Uropathogens in Catheterized Patients
Sponsor:
National Multiple Sclerosis Center
Organization:
National Multiple Sclerosis Center
Study Overview
Official Title:
Pilot Study to Evaluate the Efficacy of Antiseptic Bladder Lavage Versus Pulsatile Lavage With Physiologic Serum in Catheterized Patients With Asymptomatic Bacteriuria With Uropathogens
Status:
WITHDRAWN
Status Verified Date:
2020-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no clinical investigator present
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In patients with advanced multiple sclerosis permanent urinary catheters are often used to manage the urinary incontinence and bladder emptying problems These catheters will lead to urinary tract infection blocking of the catheter etc Especially infections with certain bacteria such as proteus enterobacteriaceae and ESBL producing enterobacteriaceae and pseudomonas can pose a problem for the hospital infection control and for the patient
This study wants to evaluate the potential role of regular bladder lavage with saline a solution of betadine an acid solution of acetic acid and of URotainer Twin Suby G Braunin the decontamination of these bladders and the prevention of clinically relevant urinary tract infections
This study wants to evaluate the potential role of regular bladder lavage with saline a solution of betadine an acid solution of acetic acid and of URotainer Twin Suby G Braunin the decontamination of these bladders and the prevention of clinically relevant urinary tract infections
Detailed Description:
PAtients will be selected from the catheterised patient population of the National MS Center in Belgium for this prospective randomised comparative pilot studyon bladder lavage
The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use
According to the type of bacteria that is cultured from the urine patients will be allocated to one of 4 subgroups
30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution
20 patients will revieve bladder lavage with acetic acid solutions
10 patients will recieve bladder lavage with saline
10 patients will receive bladder lavage with Urotainer Suby G
The effect will be measured by two repeat urine cultures after the bladder lavage 2days and 5 days
From a safety perspective and to assess the irritation caused by the lavage white blood cell counts in the urine will be done
Adverse events will be monitored according to GCP regulations
The potential benefit for the patient is a reduction in number of clinical urinary tract infections and a reduction of antibiotic use
According to the type of bacteria that is cultured from the urine patients will be allocated to one of 4 subgroups
30 patients will recieve bladder lavage with a Isobetadine Dermicum Solution
20 patients will revieve bladder lavage with acetic acid solutions
10 patients will recieve bladder lavage with saline
10 patients will receive bladder lavage with Urotainer Suby G
The effect will be measured by two repeat urine cultures after the bladder lavage 2days and 5 days
From a safety perspective and to assess the irritation caused by the lavage white blood cell counts in the urine will be done
Adverse events will be monitored according to GCP regulations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None